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A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma


Inclusion Criteria:



- Cytokine refractory metastatic renal cell carcinoma with clear cell component

- Radiographic evidence of disease progression during or within 9 months of completion
of 1 cytokine therapy

- Prior nephrectomy

Exclusion Criteria:

- Prior treatment with any systemic therapy other than 1 cytokine therapy

- History of or known brain metastases

- Uncontrolled hypertension or other significant cardiac events within the 12 months
prior to study start

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

Outcome Description:

Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome Time Frame:

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181006

NCT ID:

NCT00077974

Start Date:

February 2004

Completion Date:

September 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteMilwaukee, Wisconsin  53215